Phase 4
N=28
The Effects of Vyvanse(TM) on Brain Hemodynamics and Reading
Attention Deficit/Hyperactivity Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00733356 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcome: Primary: Gray Oral Reading Rest, Fourth Edition (GORT-4) — 8.27 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Vyvanse (Drug)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Kimberley Lakes
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gray Oral Reading Rest, Fourth Edition (GORT-4) |
8.27 | — |
Summary
This is a single-blind, Investigator Initiated study to evaluate the safety and efficacy of Vyvanse™ and provide pilot data in two areas: (1) on the use of Near-Infrared Spectroscopy to detect medication effects in children with ADHD; and (2) on the influence of Vyvanse ™ on reading fluency and comprehension, over a period of approximately 6-8 weeks. Subjects will be between the ages of 6 and 12 at the beginning of the study.
Eligibility Criteria
Inclusion Criteria
- Females of child-bearing potential must have a negative pregnancy test.
- Subjects must meet DSM-IV-TR™ criteria for a primary diagnosis of ADHD.
- Subjects must have an ADHDRS-IV-Parent: Inv total score at least 1.5 standard deviations above the age and gender norms.
- The subject is functioning at an age appropriate level intellectually as determined by an IQ score of ≥ 80 on the Kaufman Brief Intelligence Test.
- The subject and subject's parent or legal guardian must be willing and able to comply with all the testing and dosing requirements in this study.
- Subject has blood pressure measurements within the 95th percentile for age, gender, and height.
- All subjects and their parents must be able to communicate effectively in English with the doctor and his/her staff without the aid of an interpreter.
Exclusion Criteria
- Subject has any documented, current, controlled psychiatric illness [except Oppositional Defiant Disorder (ODD)]. The child may continue participating in a behavior modification program during this study as long as he/she has been participating in the program for at least one month at the time of the baseline visit.
- Subject has Conduct Disorder (CD).
- Subject has a documented allergy, hypersensitivity or intolerance to amphetamines, which is the class of drug to which Vyvanse™ belongs.
- Subject has failed to respond to one or more adequate courses (dose and duration) of amphetamine therapy.
- Subject has a recent history (within the past 6 months) of suspected substance abuse or dependence disorder (excluding nicotine).
- Subject had a history of seizures during the last two years (exclusive of febrile seizures), a tic disorder, or a current diagnosis and/or family history of Tourette's Disorder.
- Subject has a history of heart abnormalities that the study doctor feels would exclude him/her from the study.
- Subject has a positive urine drug result at the screening visit.
- Subject weighs less than 50 pounds (22.7 kg).
- Subject has taken another investigational drug within the last 30 days prior to the screening visit.
- Subject has any reported history of abnormal thyroid function.
- Subject has any clinically significant electrocardiogram reading (an electrical recording of the heart - ECG) or laboratory abnormalities at the screening and/or baseline visits.
- The study doctor feels that the subject's safety would be jeopardized if entered in this study due to a current illness or medical condition. Mild, stable asthma is not exclusionary.
- Subject is taking any medication that is excluded.
Data sourced from ClinicalTrials.gov (NCT00733356). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.